RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Nov 12, 2014 · Event occurred Oct 16, 2014
Report 3005985723-2014-00189 · MDR key 4268013
Device
Generic name
Compartmental Knee Prosthesis
Manufacturer
Mako SurgicalModel number
180602Lot number
26130214-01
Product problems
- Device Contaminated During Manufacture or Shipping
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. PRIOR TO IMPLANTING THE TIBIAL BASEPLATE, THE SURGEON NOTICED THERE WAS RESIDUE ON THE TOP SURFACE OF THE IMPLANT. THE IMPLANT WAS NOT USED AND A NEW IMPLANT WAS USED. THIS EVENT DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT WAS COMPLETED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS OBTAINED.